Clinical trial · Observational
Peritumoral MRE Stiffness for Predicting Resection Margin Status and Recurrence in Liver Cancer
A Prospective Study on the Association Between Peritumoral Elasticity Measured by Three-Dimensional Magnetic Resonance Elastography and Pathological Resection Margin Status and Postoperative Recurrence in Patients With Liver Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Microscopic residual tumor at the resection margin is a critical risk factor for recurrence in patients undergoing hepatectomy for liver cancer, yet current detection relies solely on postoperative pathological examination of the resected specimen, which reflects only the removed tissue rather than the actual remnant liver in the patient. How to non-invasively detect residual tumor at the resection margin of the remnant liver after surgery remains an important unresolved problem in the surgical management of liver cancer. We hypothesize that tissue stiffness at the resection margin of the remnant liver, measured by postoperative three-dimensional magnetic resonance elastography (3D-MRE), may reflect microscopic residual tumor and may therefore correlate with pathological resection margin status and be predictive of postoperative tumor recurrence. This study aims to prospectively evaluate the diagnostic performance of postoperative 3D-MRE in detecting residual tumor at the resection margin, using pathological resection margin status as the reference standard, and to further assess its value in predicting tumor recurrence in patients undergoing hepatectomy for liver cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepato Cellular Carcinoma | Cholangiocarcinoma | PROBABILISTIC | 0.70 |
| Intrahepatic Bile Duct Carcinoma | Intrahepatic Cholangiocarcinoma | ALIAS | 0.90 |
| Metastatic Hepatocellular Carcinoma | Hepatocellular Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Three-Dimensional Magnetic Resonance Elastography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin
- timeFrame
- Postoperative day 7-14
- description
- Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of 3D-MRE-derived stiffness parameters at the resection margin of the remnant liver, compared with pathological resection margin status (R0 vs. R1) of the surgical specimen as the reference standard.
Secondary outcomes (4)
- measure
- Recurrence-Free Survival (RFS)
- timeFrame
- Up to 2 years after surgery
- description
- Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs
- measure
- Overall Survival (OS)
- timeFrame
- Up to 2 years after surgery
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-80 years * Pathologically confirmed diagnosis of hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer) * Underwent curative-intent hepatectomy with available postoperative pathological resection margin assessment * Child-Pugh class A or B liver function (for patients with primary liver cancer) * Able to undergo 3D-MRE examination at postoperative day 7-14 * Provision of signed and dated informed consent Exclusion Criteria: * Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia) * Palliative or non-curative surgery (R2 resection) * Presence of unresectable extrahepatic disease at the time of surgery * Reoperation or unplanned return to surgery within 14 days after the initial hepatectomy * Severe postoperative complications precluding MRI examination at postoperative day 7-14 (e.g., unstable vital signs, need for intensive care) * Death within 14 days after surgery from non-tumor-related causes * Prior history of liver resection or liver transplantation * Pregnant or breastfeeding women * Anticipated poor compliance with postoperative MRE examination or follow-up
References
Publications (0)
Data not yet available